Abstract：
UNASSIGNED: The objective of this study was to monitor and identify adverse events (AEs) associated with topotecan, a medication used for the treatment of solid tumors, in order to improve patient safety and guide medication usage.
UNASSIGNED: To assess the disproportionality of topotecan-related AEs in real-world data, four algorithms (ROR, PRR, BCPNN, and EBGM) were employed as measures to detect signals of topotecan-associated AEs.
UNASSIGNED: A statistical analysis was conducted using data from the FAERS database, encompassing 9,511,161 case reports from 2004Q1 to 2021Q4. Among these reports, 1,896 were identified as primary suspected (PS) AEs related to topotecan, and 155 topotecan-related adverse drug reactions (ADRs) at the preferred terms (PTs) level were selected. The occurrence of topotecan-induced ADRs was analyzed across 23 organ systems. The analysis revealed several expected ADRs, such as anemia, nausea, and vomiting, which were consistent with the drug labels. Additionally, unexpected significant ADRs associated with eye disorders at the system organ class (SOC) level were identified, indicating potential adverse effects not currently mentioned in the drug instructions.
UNASSIGNED: This study identified new and unexpected signals of adverse drug reactions (ADRs) related to topotecan, providing valuable insights into the relationship between ADRs and topotecan usage. The findings highlight the importance of ongoing monitoring and surveillance to detect and manage AEs effectively, ultimately improving patient safety during topotecan treatment.
UNASSIGNED: To assess the disproportionality of topotecan-related AEs in real-world data, four algorithms (ROR, PRR, BCPNN, and EBGM) were employed as measures to detect signals of topotecan-associated AEs.
UNASSIGNED: A statistical analysis was conducted using data from the FAERS database, encompassing 9,511,161 case reports from 2004Q1 to 2021Q4. Among these reports, 1,896 were identified as primary suspected (PS) AEs related to topotecan, and 155 topotecan-related adverse drug reactions (ADRs) at the preferred terms (PTs) level were selected. The occurrence of topotecan-induced ADRs was analyzed across 23 organ systems. The analysis revealed several expected ADRs, such as anemia, nausea, and vomiting, which were consistent with the drug labels. Additionally, unexpected significant ADRs associated with eye disorders at the system organ class (SOC) level were identified, indicating potential adverse effects not currently mentioned in the drug instructions.
UNASSIGNED: This study identified new and unexpected signals of adverse drug reactions (ADRs) related to topotecan, providing valuable insights into the relationship between ADRs and topotecan usage. The findings highlight the importance of ongoing monitoring and surveillance to detect and manage AEs effectively, ultimately improving patient safety during topotecan treatment.
摘要：
■本研究的目的是监测和识别与托泊替康相关的不良事件（AE），一种用于治疗实体瘤的药物，以提高患者安全和指导用药。
■为了评估现实世界数据中与托普替康相关的AE的不相称性，四种算法(ROR，PRR,BCPNN,和EBGM）被用作检测拓扑替康相关AE信号的措施。
■使用FAERS数据库中的数据进行了统计分析，涵盖2004Q1至2021Q4的9,511,161例病例报告。在这些报告中,1,896例被确定为与托泊替康有关的主要可疑（PS）AE，在首选术语（PT）水平上选择了155例托泊替康相关的药物不良反应（ADR）。在23个器官系统中分析了拓扑替康诱导的ADR的发生。分析揭示了几个预期的ADR，比如贫血,恶心,呕吐,与药物标签一致。此外,发现了与系统器官类别（SOC）水平的眼部疾病相关的意外重大ADR，表明药物说明书中目前未提及的潜在不良反应。
■这项研究发现了与托泊替康有关的药物不良反应（ADR）的新的和意外的信号，提供对ADR和拓扑替康使用之间关系的有价值的见解。研究结果强调了持续监测和监督对有效检测和管理AE的重要性，最终改善托泊替康治疗期间的患者安全。
■为了评估现实世界数据中与托普替康相关的AE的不相称性，四种算法(ROR，PRR,BCPNN,和EBGM）被用作检测拓扑替康相关AE信号的措施。
■使用FAERS数据库中的数据进行了统计分析，涵盖2004Q1至2021Q4的9,511,161例病例报告。在这些报告中,1,896例被确定为与托泊替康有关的主要可疑（PS）AE，在首选术语（PT）水平上选择了155例托泊替康相关的药物不良反应（ADR）。在23个器官系统中分析了拓扑替康诱导的ADR的发生。分析揭示了几个预期的ADR，比如贫血,恶心,呕吐,与药物标签一致。此外,发现了与系统器官类别（SOC）水平的眼部疾病相关的意外重大ADR，表明药物说明书中目前未提及的潜在不良反应。
■这项研究发现了与托泊替康有关的药物不良反应（ADR）的新的和意外的信号，提供对ADR和拓扑替康使用之间关系的有价值的见解。研究结果强调了持续监测和监督对有效检测和管理AE的重要性，最终改善托泊替康治疗期间的患者安全。
